UMIN-CTR Clinical Trial

Basic information
Public title	Hair growth trial
Acronym	Hair growth trial
Scientific Title	Hair thinning improvement effect evaluation test of hair restorer
Scientific Title:Acronym	Hair growth trial
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the effect of the product on hair growth in a 24-week continuous use test in healthy adult males and females with symptoms of thinning hair.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Photo Trichogram (Growth rate, Hair diameter, Anagen hair percentage,Hair number)
Key secondary outcomes	Stratum corneum water content of the scalp,Questionnaire survey,Head photography (front side of head, back side of head),Adverse event investigation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Subjects use the test product twice daily for 24 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	[1]Healthy Japanese males and females aged between 30 and 60 at the time of informed consent [2]Subjects with feeling of thinning hair and hair loss [3]Subjects who don't have full head of gray hair or are dyeing gray hair [4]Subjects who can agree to cut hair locally approximately 1.0 cm x 1.0 cm near the crown on each visit day [5]Subjects who can agree to keep the conditions such as hair conditioning and hair dyeing constant on each visit day [6]Subjects who can obtain written consent at their own discretion before the study begins
Key exclusion criteria	[1]Subjects with pathological hair loss such as alopecia areata [2]Subjects with scalp diseases other than hair loss (eg, head eczema, seborrheic eczema, psoriasis, tinea capitis, and other scalp infections) [3]Subject with reduced or abnormal thyroid function [4]Subjects with photosensitivity disorder [5]Subjects receiving "hormone replacement therapy" or taking oral contraceptives within one year [6]Subjects who are pregnant or lactating, or who intend to become pregnant [7]Subject with atopic dermatitis [8]Subjects who habitually apply or take external preparations, oral medicines, supplements, etc. that may affect the condition of the head [9]Subjects with a history of hypersensitivity (allergies) to hair growth agents, hair restorer, cosmetics (shampoo, etc.), or hypersensitivity to other medicines. [10]Subjects who have been treated with radiation therapy to the head or cancer chemotherapy within the last 6 months, or who will be treated within the next 2 months after the end of the study [11]Subjects who regularly use wigs during the study period, subjects who have undergone hair transplantation or hair growth, or subjects who are scheduled during the study period [12]Subjects who have been treated with pharmaceutical hair growth agents (such as finasteride, minoxidil, or carpronium chloride-containing preparations) within the past 6 months [13]Subjects who have used existing hair growth agents and hair restorer within the past 2 months, regardless of whether they are pharmaceutical products or quasi-drugs. [14]Subjects currently using medical medications known to cause trichotillomania or hirsutism (eg, phenytoin for epilepsy) [15]Subjects working for cosmetics companies and pharmaceutical companies [16]Subjects judged to be ineligible for this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Zip code	610-0394
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Masaaki Middle name Last name Yamamura
Organization	Nikoderm Research Inc.
Division name	Evaluation Division
Zip code	541-0052
Address	1-6-14 Azuchimachi,Chuo-ku,Osaka City, OSAKA, Japan
TEL	06-6125-3501
Homepage URL
Email	myamamura@nikkolgroup.com

Sponsor
Institute	Yamada Bee Company, Inc.
Institute
Department

Funding Source
Organization	Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Society of Glycative Stress Research
Address	5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel	03-6709-8842
Email	rinri-glycativestress@antiaging-bank.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社ニコダームリサーチ（大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 08 Month 05 Day
Date of IRB	2021 Year 08 Month 18 Day
Anticipated trial start date	2021 Year 08 Month 19 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 19 Day
Last modified on	2022 Year 08 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051555